THE SUBCOMMITTEE ON VETERANS AFFAIRS
EVIDENCE
OTTAWA, Wednesday, November 30, 2022
The Subcommittee on Veterans Affairs met with videoconference this day at 12 p.m. [ET] to examine and report on issues relating to Veterans Affairs, including services and benefits provided, commemorative activities, and the continuing implementation of the Veteran’s Well-being Act.
Senator David Richards (Chair) in the chair.
[English]
The Chair: Honourable senators, welcome to this meeting of the Standing Senate Subcommittee on Veterans Affairs. I am David Richards, senator from New Brunswick, chair of the subcommittee. I’m joined by my fellow subcommittee members, Senator Boisvenu, deputy chair from Quebec; Senator Yussuff from Ontario; and we hope to be joined soon by Senator Anderson from the Northwest Territories, Senator Duncan from the Yukon and Senator Cardozo.
Today, we continue our study into emerging treatment for veterans suffering from occupational stress injuries. For our witnesses, we welcome from Health Canada Shannon Nix, Associate Assistant Deputy Minister, Controlled Substances and Cannabis Branch; and Karen Reynolds, Director General, Pharmaceutical Drugs Directorate, Health Products and Food Branch. By video conference from the Canadian Institute of Health Research we have Samuel Weiss, Scientific Director, CIHR Institute of Neurosciences, Mental Health and Addiction. And Stephanie Priest is the Acting Director General, Centre for Mental Health and Wellbeing, Public Health Agency of Canada. Thank you for joining us.
We now invite you to provide your opening remarks, which will be followed by questions from our members. We will begin with a presentation by Ms. Shannon Nix. I remind you that you have five minutes for opening remarks. Ms. Nix, you may begin when you are ready.
Shannon Nix, Associate Assistant Deputy Minister, Controlled Substances and Cannabis Branch, Health Canada: Thank you very much for the invitation to speak about emerging treatments for post-traumatic stress disorder, or PTSD. We’re deeply concerned that veterans continue to experience PTSD at a higher rate than the general population.
I would like to start by explaining how psychedelic drugs are regulated. In Canada, all psychedelic drugs are subject to the Food and Drug Act and its regulations. Most psychedelic drugs, including ketamine, psilocybin and MDMA, are also controlled substances, which means they are also subject to the Controlled Drugs and Substances Act and its regulations.
In order to legally conduct activities with psychedelic controlled substances in Canada, appropriate authorizations from Health Canada are needed under both acts. Psychedelic-assisted psychotherapy has shown promise in clinical trials as an emerging treatment for patients with mental health conditions. In particular, the use of MDMA in combination with psychotherapy is showing promise as a treatment option for PTSD.
However, with the exception of ketamine, no psychedelic drugs have been authorized for clinical use in Canada or elsewhere. Evidence related to the effectiveness of psychedelic drugs in the treatment of PTSD is still very much under development.
To that end, I would like to briefly comment on Canada’s drug review and authorization process under the FDA and the important role that clinical trials play in generating evidence. Before a drug product is authorized for sale in Canada, the drug manufacturer must submit scientific evidence of the product’s safety, efficacy and quality to Health Canada for review and authorization. This includes results of clinical trials conducted on humans that are designed to evaluate safety and effectiveness.
I mentioned that, currently, ketamine is the only psychedelic drug that has been authorized for sale in Canada. One form of ketamine, esketamine, has been authorized by Health Canada for use in the treatment of serious forms of depression. Ketamine is most often used as an intravenous anesthetic for surgical purposes, but it is also being used off-label for the treatment of mental health conditions.
Health Canada is aware of clinics offering ketamine-assisted psychotherapy for the treatment of mental health disorders, including PTSD. A health practitioner’s decision to prescribe a drug off-label is a practice of medicine that falls under provincial and territorial jurisdiction. The use of ketamine as a potential treatment option for PTSD continues to be studied.
Apart from ketamine, psilocybin and MDMA are the two psychedelic drugs most widely being examined in conjunction with psychotherapy for the treatment of a variety of mental health conditions including PTSD. Research on MDMA-assisted psychotherapy for PTSD is the furthest along. We understand that several phase 3 clinical trials are being conducted by MAPS, which is the Multidisciplinary Association for Psychedelic Studies. Earlier this month, MAPS announced that they had completed gathering phase 3 clinical data on MDMA as a potential treatment for PTSD and hoped to submit a final package to American regulators for the drug’s authorization in 2023.
I’m pleased to report that there are several PTSD-related clinical trials being conducted in Canada as well. As of this month, there are nine clinical trials studying MDMA, three studying psilocybin — these have been authorized by Health Canada — and there’s also one clinical trial authorized for ketamine in the treatment of PTSD.
Clinical research is a critical step in the generation of high-quality evidence needed to better understand the health benefits and harms associated with psychedelic drugs. Clinical trials protect patients by providing a framework so that a potential treatment is administered in accordance with national and international ethical, medical and scientific standards.
The Government of Canada provides funding for health research in Canada, including clinical trials through the Canadian Institutes of Health Research. In particular, CIHR has launched funding opportunities to support the creation of new knowledge to address existing and emerging gaps in PTSD as it relates to public safety personnel in Canada. CIHR has also launched a funding opportunity that will provide up to $3 million to support clinical trials to assess the safety and efficacy of psilocybin-assisted psychotherapy for the treatment of substance use and mental health disorders.
For drugs that have not yet been authorized in Canada, Health Canada has a program in place to provide access for emergency treatment purposes. Health Canada’s Special Access Program allows health care professionals to request access to unauthorized drugs on behalf of their patients. Requests through this program are for drugs that have shown promise in clinical trials but have not yet been authorized for sale in Canada. To access a drug through this program, health care professionals need to demonstrate that the requested drugs are for the treatment of a serious or life-threatening health condition, and that conventional therapies have failed, are unsuitable or are unavailable in Canada.
In instances where there is a medical need and it can be demonstrated that access to psychedelic controlled substances is not possible or suitable through either clinical trials or the Special Access Program, individuals can also apply for what is known as a subsection 56(1) exemption under the Controlled Drugs and Substances Act.
Subsection 56(1) is a discretionary power that permits the Minister of Mental Health and Addictions and Associate Minister of Health to exempt individuals from the application of any provision under the Controlled Drugs and Substances Act or its regulations for scientific or medical purposes, or for a purpose that is otherwise in the public interest.
The Special Access Program and the subsection 56(1) exemptions are not meant to be mechanisms to encourage the early use of unauthorized drugs or as means of circumventing clinical development or the established drug review and authorization process. However, Health Canada recognizes that there are times when access to unauthorized drugs might be appropriate.
The Chair: Ms. Nix, could you finish up, please? It has been over five minutes. Thank you. Then we will get to questions.
Ms. Nix: Sure. We understand there is excitement and anticipation around psychedelics as a treatment option for mental health conditions like PTSD; however, the clinical research and the subsequent drug review and authorization process to protect patients are not steps that should be skipped over. There are steps in place to ensure that Canadians have access to high-quality safe medications, and it is in the best interests of Canadians — as patients, family members and caregivers — that we generate robust clinical evidence on the quality, safety and efficacy of these drugs.
I will stop there, given that I have gone over five minutes. My colleagues and I are very happy to answer any questions you might have.
The Chair: Thank you, Ms. Nix. We’ll proceed to questions.
Before we do, I would like to ask participants in the room to please refrain from leaning in too close to the microphone, or remove your earpiece when doing so. That will avoid any sound feedback that could negatively affect committee staff in the room.
We are now joined by Senators Anderson and Deacon from the Northwest Territories and Ontario, respectively. We will go to questions now, starting with Senator Boisvenu, the deputy chair.
[Translation]
Senator Boisvenu: I’d like to thank the witnesses for being with us today.
My question is for Ms. Reynolds or Ms. Nix. Is the United States much further ahead in terms of experimenting with psychedelics, particularly MDMA, in treating veterans?
[English]
Ms. Nix: I will turn to Dr. Weiss for that.
Samuel Weiss, Scientific Director, CIHR Institute of Neurosciences, Mental Health and Addiction, Canadian Institute of Health Research: Yes, good afternoon. I am aware of more clinical trials with psychedelics in the U.S., but I am not aware of whether there have been more clinical trials with veterans in the United States.
[Translation]
Senator Boisvenu: When drugs tested in the United States prove to be effective, should the process be repeated in Canada or can American studies be relied upon to approve this type of medication?
[English]
Karen Reynolds, Director General, Pharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada: Thank you, senator, for the question. Health Canada will accept international studies as part of a new drug submission that any sponsor may submit to the department to gain authorization for a new drug. Not all trials need to be conducted in Canada in order to submit an application to Health Canada.
[Translation]
Senator Boisvenu: It is good to hear that the process doesn’t have to start all over again.
We know that the United States has a longer history of treating veterans than Canada. In Canada, I believe that the current generation of veterans is the first to be treated with this type of medication, whereas in the United States it has been in use since the 1980s.
Does the fact that Canada has fewer veterans and fewer clinics limit the testing of these drugs?
[English]
Ms. Nix: Dr. Weiss, could you provide perspective?
Mr. Weiss: I am not aware of standard treatments using psychedelics for veterans since the 1980s because, in fact, most of the clinical trials for psychedelic-assisted psychotherapy really only began within the last 5 to 10 years.
Specifically, as it relates to psychedelic-assisted psychotherapy, I think this is much more recent, to my understanding.
The Chair: Ms. Priest, do you have anything to add on this matter?
Stephanie Priest, Acting Director General, Centre for Mental Health and Wellbeing, Public Health Agency of Canada: I do not have anything further to say from a public health perspective. Our work has been fairly focused on upstream materials that we can create, collate and collaborate with partners under the Federal Framework on Posttraumatic Stress Disorder.
The Chair: Thank you.
Senator Anderson: You spoke of 13 ongoing clinical trials. What are the timelines and in what areas of Canada are these trials happening? How are the participants chosen?
Ms. Reynolds: Thank you very much, senator, for the question.
I do not have that level of detail with me today on those particular clinical trials. I would need to commit to follow up.
Senator Anderson: That would be great if you can follow up in writing.
Ms. Nix: Perhaps Dr. Weiss might have detail on clinical trials that are under way, but we can certainly follow up in writing with a more comprehensive answer.
Mr. Weiss: I am only aware of clinical trials under way that are funded by CIHR. Those clinical trials that are funded are not involving veterans. They are involving individuals in the general population, in particular those with major depressive disorder or treatment-resistant depression. There is one additional trial on PTSD, I believe, that has just been funded by the Centre for Research on Pandemic Preparedness and Health Emergencies, but it is not with veterans. It is focused on frontline health care workers.
Senator Anderson: Are there any clinical trials happening with veterans?
Mr. Weiss: In Canada?
Senator Anderson: Yes.
Mr. Weiss: Not to my knowledge.
Senator Anderson: Can you tell us what the timelines are from the trials to their submissions to approval? How long is that process? What are the barriers currently?
Ms. Reynolds: Thank you for the question, Senator Anderson. As I mentioned, I do not have the timelines for the particular trials that are being undertaken at this time. As you can appreciate, they can occur over a variety of timelines.
In terms of when it comes to Health Canada approval, our standard review time of an application for a new drug submission is 300 days. That being said, we do have some accelerated review pathways. For example, we have a pathway for priority review when there are unmet medical needs, and a sponsor can apply through that pathway. That pathway reduces the review time to 180 days.
Senator Yussuff: Let me thank the witnesses for being here today. As you know, our work is about trying to assess the level of supports that we can provide to veterans in this country who are suffering from PTSD. There are a number of other groups of people who will benefit from this effort. It is good to hear that there are a number of trials going on in the country because that gives us our own milieu to look at the evidence and evaluate it. Putting that aside, good work has been done in the United States on using these different drugs.
In the context of wanting to ensure that we can accelerate this process to get treatment to veterans, is this department evaluating and learning from this? Alberta is one of the first provinces that has taken the position to use some of these medications to potentially deal with PTSD. Are there other provinces thinking of doing the same thing, based upon your knowledge within the department? If so, perhaps you could share that with us.
I have a couple more questions specific to studies and looking to what other jurisdictions do.
Ms. Nix: Thank you very much for your question, Senator Yussuff. We at Health Canada would be responsible for authorizing the sale of drugs; provinces and territories are responsible for regulating the practice of medicine and delivering health care services.
What Alberta has announced in its new regulations are intended to provide an additional level of safeguards and oversight into how psychedelic health services are delivered in the province.
Federal drug laws will continue to apply, including the requirements around the sale of any drug needing to be authorized by Health Canada before it can be marketed and prescribed in Canada. We are working closely with Alberta to understand the scope of these new regulations. To the best of my knowledge, they are the only province that has started work in this space.
Senator Yussuff: What will be involved in developing clinical trials for psychedelic-assisted therapies? Can Health Canada or any other department or agency of the federal government initiate a clinical trial? If so, what are some examples? Who funds this? I did hear Dr. Weiss talk about CIHR funding one of these studies, but what other departments might be able to fund this? Could Veterans Affairs fund its own study if they chose to do so?
Ms. Reynolds: I can speak briefly to clinical trial applications. Those can come from a clinical trial investigator or, as you can appreciate, can be sponsored sometimes by a pharmaceutical company, for example.
With respect to those applications, in the recent past, Health Canada has been working to increase knowledge in the community around what it takes to put a clinical trial application together. We have been holding 101 sessions on our general requirements for clinical trial applications to reach the broader community and have also been following up. Sometimes we get individual investigator outreach and then staff follows up. This often precedes an application to help familiarize themselves with what our regulatory requirements are so that they can turn their minds to whether or not they would like to submit an application.
We are working in this area to fill some of those gaps for individuals or companies that are new to this space in order to ease the path for successful clinical trials to come into Canada.
Perhaps, Senator Yussuff, Dr. Weiss might have some further comments.
Mr. Weiss: Yes. Thank you for that question, senator. We collaborate closely with Veterans Affairs Canada and we have collaborated on cannabis research with Veterans Affairs. Since we are the health research agency that funds clinical trials through peer-reviewed assessment of these trials, we can definitely collaborate with Veterans Affairs at any point should there be an interest in expanding the scope and breadth of the clinical trials that look at psychedelic-assisted psychotherapy. That is definitely a possibility.
Senator Yussuff: Given the limited amount of research we’re seeing in this country in terms of clinical trials for psychedelics — and, this is probably a biased question — would you suggest that we could do more?
Mr. Weiss: I think researchers will always argue that more research is a good thing.
CIHR is responsible for many areas of research. We are trying to cover quite a breadth of areas in both mental health and substance use. Of course, at this point in time we are trying to tackle a number of areas, in particular, post-pandemic areas related to mental health of the young population in Canada. Children and youth are a high priority and the toxic drug crisis in Canada is also an area that is receiving considerable attention through research.
That said, I think more research in areas that show promise, like psychedelic-assisted psychotherapy, would be welcomed by all.
The Chair: Thank you. Ms. Reynolds, do you have something more to say?
Ms. Reynolds: No, sir.
The Chair: I will go to Ms. Priest to see if she has any follow-up before we continue.
Ms. Priest: No, thank you. I do not think I have anything to add to the discussion so far apart from echoing what Dr. Weiss was saying with respect to gathering information about what works and why it works across a number of different populations. Our role at the Public Health Agency with the PTSD framework is to be able to start to coordinate that more effectively across the federal government, and that is a work-in-progress. Thank you.
The Chair: Thank you very much.
We are now joined by Senator Cardozo. Welcome to this subcommittee, senator, and welcome to the Senate.
Senator Deacon, before we go to second round, did you have anything to add?
Senator M. Deacon: I would love to add to the first round.
Thank you to all of our witnesses for being here. As my colleague just said, we are undertaking this work because it is important that we explore all options with a sense of urgency for our veterans, who need it right now.
Some of my questions have been answered. However, I do want to understand more completely. Ultimately, at the end of the day, any decisions on the viability of these therapies will be made by your departments. In our mind, we impatiently might think that we know what success is. However, from your perspective, what does success look like to you? What do you need to see in these clinical trials in order to determine if something is there that should be approved and offered to our veterans community, and soon?
Ms. Reynolds: Thank you for the question, Senator Deacon.
In order for a new drug, or any drug, to be approved in Canada, there are three lenses that we look at: The safety of the drug, the quality of the drug and the efficacy of the drug. Does it work for what it is being purported to be used? Our standards of evidence are the same for all new drugs. That is, under the Food and Drug Regulations they have to meet that bar.
As we have already mentioned today, the research for the use of psychedelics in psychedelic-assisted psychotherapy for PTSD is progressing. It is promising, but it is my understanding that more research needs to be done in most areas, prior to the ability to submit a new drug application.
That being said, I understand that the MAPS organization that my colleague Ms. Nix referred to has communicated publicly earlier this month that they have complete the phase 3 clinical trials, which is the last level or the last phase of clinical trials prior to seeking market authorization on MDMA for PTSD. They will be submitting a final package to the United States Food and Drug Administration for approval in 2023. I think that is a promising development for MDMA in this space in terms of a potential authorized product.
We do not have understanding of when an application may be submitted to Health Canada yet.
Senator M. Deacon: It has garnered more interest. Are you getting more organizations applying to undergo the trials? Is there an uptick?
Ms. Reynolds: We have received more applications more recently. There certainly is more of an interest in recent times.
Senator Boisvenu: My question will be for Dr. Weiss.
[Translation]
Doctor Weiss, there seems to be a debate within Health Canada. Listening to its officials today, they sound very supportive of the experimental psychotherapeutic use of psychedelics for veterans. That is not the position of Veterans Affairs Canada, which is opposed to psychedelic-based psychotherapy. In your view, how will this apparent conflict between Veterans Affairs Canada and Health Canada be handled?
[English]
Mr. Weiss: Thank you for the question, senator. To my understanding, I don’t believe I have heard Veterans Affairs Canada not being supportive of experimentation and clinical testing of psychedelic-assisted psychotherapy for veterans or for the general population.
If I understand the question, it’s probably more related to whether they are supportive of providing funding to clinicians who offer psychedelic-assisted psychotherapy at this point, when it has not yet reached the scientific and regulatory threshold for approval. But I have not heard that they are not interested in seeing the research and science go forward. In my conversations with Veterans Affairs, they seem quite interested in this work.
[Translation]
Senator Boisvenu: Do Health Canada officials share Dr. Weiss’ opinion on this? In their dealings with Veterans Affairs Canada, are they expressing similar views as Health Canada’s or are there seemingly conflicting opinions between the two organizations?
[English]
Ms. Nix: Thank you, senator, for the opportunity to provide some additional comments.
I agree with Dr. Weiss. I have not heard of any hesitancy on the part of my counterparts at Veterans Affairs in terms of better understanding the science and evidence around psychedelic-assisted psychotherapy in the treatment of any number of mental health conditions that veterans may be experiencing.
Senator Anderson: There’s recognition of the gaps and lack of services for veterans. It recently came to light that at least four or five veterans were given the option of MAID by a Veterans Affairs caseworker.
Does Health Canada maintain statistics on applications for special use or monitor in relation to the toxic drug crisis specifically for veterans?
Ms. Nix: Can I ask you to rephrase your question? I’m not sure I’m quite understanding it.
Senator Anderson: In your involvement with Health Canada, do you have any specific statistics for veterans that may be involved — I heard the toxic drug crisis mentioned. I imagine that if you can’t get drugs legally, you would access them illegally — or how that may impact veterans?
We’ve also heard from previous testimony that special access use is not a viable option — that it is not often approved and that it does not appear to be a reliable source for veterans.
I am wondering, from Health Canada’s perspective, if you see that the gaps in services for veterans are putting them in a predicament that is probably classified as a crisis because they are not able to access services and now are being provided the option of MAID because those services are either lacking or non-existent.
Ms. Nix: Thank you for that question. I would start by saying that we don’t collect data at the level of understanding who are veterans and who aren’t. I would turn to Karen to speak perhaps to the Special Access Program and the ability to access that.
Ms. Reynolds: Thank you, senator, for the question. The Special Access Program, as you may be aware, provides access to products that are not otherwise available for sale for serious and life-threatening conditions.
In terms of overall approvals through the Special Access Program, for psilocybin, we have 44 approvals for 58 patients; and for MDMA, we have not approved any. We have had 11 requests but have not been able to approve any because we do not have a source of pharmaceutical-grade MDMA that is available. Under the Special Access Program, we look to provide patients with what we call pharmaceutical-grade or good manufacturing practice-compliant product so that we know that it’s a pure product and doesn’t contain any other substances or whatnot. Those are the numbers in terms of what we have approved.
Senator Anderson: Do you know how many applicants you have had?
Ms. Reynolds: In terms of total requests, we have had 62 requests by patients for psilocybin. As I mentioned, 44 of 58 have been approved to date. For MDMA, we have had 11 requests for 11 patients but have not authorized any because we do not have a source of supply for those patients.
Senator Yussuff: The majority of studies on psychedelics that we are talking about are done in the U.S. However, of course, the U.S. is not the only country that is authorizing the use of psychedelics.
Could you comment about countries other than the U.S. that have been using psychedelics to treat PTSD? And what is Health Canada’s evaluation of the evidence from other countries?
Ms. Reynolds: Thank you, Senator Yussuff, for the question. I don’t have information on what is happening in other countries because we’re not yet at the stage of a new drug submission. As I mentioned, if a sponsor were to bring forward a new drug submission, that sponsor may use clinical trials from a variety of jurisdictions if they choose. They do not have to be Canadian-only clinical trials. But since we are not yet at that stage, the work of the department and the regulator is focused on approving either submissions for special access or clinical trial applications at this time.
Senator Yussuff: I think you can appreciate that there is a crisis in the country, and specifically among our veterans. Women veterans are likely to face challenges and suicide more than men. Our work is to figure out a way to accelerate the process of getting treatment to people.
Some treatments will require not just access to the drug but will also involve therapy. The provincial government is the deliverer of health care at that level. When the department is asked to authorize drug use, the challenge is to recognize that some of these drugs can’t simply be administered without therapy; otherwise it would be a complete failure.
How does the department evaluate this if you get requests from provinces to provide for the use of these drugs and therapies for veterans who may require them? Is it simply for the province to make the decision? Will they be doing both in the context of how the drug use can be done safely? Or is the department saying, “Unless you are going to provide the therapy, we will not authorize this drug use in your jurisdiction”?
Ms. Reynolds: Thank you, Senator Yussuff, for the question. If a sponsor were to bring forward a new drug application for its intended use in psychedelic-assisted psychotherapy, the authorization, as it is for any drugs right now, would set out the appropriate conditions of use. Then once any drug is approved, in terms of its use, it is up to the prescriber to prescribe the drug for its intended use, or in some cases obviously prescribers choose to prescribe drugs off label. But it would turn to the practitioner to prescribe the drug in the way it has been authorized to be used as part of the practice of medicine. If you are talking about reimbursement and whatnot for therapy, that would indeed fall to the province or territory to make decisions on.
Senator Yussuff: Based on the evidence we have seen so far, can psychedelic therapy improve the treatment of PTSD based on what you have evaluated so far?
Ms. Reynolds: Thanks again for the question, Senator Yussuff. In terms of the clinical trials, to be clear on what Health Canada is doing right now, we are authorizing the conduct of certain clinical trials. We are not in a space of evaluating the outcomes of those clinical trials. That would only occur when a sponsor actually puts together a drug submission to authorize a medication. At that point, our evaluators would actually look at that evidence and see whether it meets the threshold to be authorized in Canada, but we don’t do that until we get a new drug submission.
[Translation]
Senator Boisvenu: Out of personal curiosity, since we still have a bit of time, and the question is for Dr. Weiss and perhaps for the people at Health Canada.
Dr. Weiss, we know that the entire psychotherapeutic process takes place in the realm of relativity, in the sense that each psychotherapy is specific to each individual. There is never a common core.
How do we evaluate the performance of a drug, given that psychedelic drugs, therefore chemical substances, will be used? How does one assess their performance in a context of relativity, as is the case with psychotherapy?
I would be interested to know the fundamental elements for assessing how well these approaches perform.
[English]
Mr. Weiss: Thank you. That’s a very good and important question. When we peer-review randomized clinical trials, normally they are looking at a single therapy on its own against a placebo, or a non-therapy, for a similar group of individuals in what we call a double-blind, where neither the person delivering the therapy or the person evaluating or the recipients of the therapy who gets the drug or who doesn’t get the drug. So it’s done in what’s called double-blind fashion.
In the case of psychedelic-assisted psychotherapy, because psychotherapy is currently the best treatment for PTSD, when we study it, for example, in a subpopulation that have PTSD, a recognized form of psychotherapy has to be administered to all recipients in the trial. One half will get the psychotherapy as well as what we call a placebo, which will be a pill or an injection of the drug, but not with the drug, just with a saline solution that would normally carry the drug. The other half gets the drug itself.
The psychotherapy is structured, delivered by a licensed, practising psychotherapist, using psychotherapy that is known to have effectiveness for PTSD. Then we see whether or not adding the psychoactive compound improves the outcome, but neither the patient nor the person administering knows who gets the psychoactive compound and who doesn’t get the psychoactive compound.
Because they are being microdosed, these psychoactive compounds don’t yield the same kind of psychoactivity or hallucinations that larger doses would, which allows it to be very carefully studied for benefit. But really, the psychotherapy itself is administered to all people in the trial. The difference is some get the psychedelic and the others don’t. That allows people who are evaluating it to see amongst this group who has improved and who has not improved and then determine whether or not that’s a consequence of the psychedelic or not.
The other important point to raise here is that, you are right, that we’re dealing with individual people, all of whom are very different, with different histories, some of whom respond better to psychotherapy and some who don’t. That’s why you have to move the trials from phases 1 and 2 — which focus a lot on safety — to something that is called a phase 3 trial that is based on the fact that you know that administering the psychotherapy and/or the psychedelic isn’t unsafe. So you increase the numbers that you test because you are no longer worried that there are going to be too many adverse events.
When it comes to phase 3 trials for psychedelic-assisted psychotherapy in veterans, none have been published yet, none has been peer-reviewed. Yes, these trials have been undertaken, but they have not yet been scrutinized by the medical and scientific community such that we can say that they are effective for veterans with PTSD.
Now, the Multidisciplinary Association for Psychedelic Studies in the U.S. has announced that phase 3 trials have been completed, and there is evidence for it. But if they have been, they have not yet been published in the scientific literature. And for us, it’s very important that they are published in the scientific literature, because through peer review, all the questions that you asked — did you ensure that the patients were similar in terms of either their age, their experiences and so on and forth; do you have data that shows, indeed, that those that received the psychedelics clearly improved to a greater extent — has to be peer-reviewed. And at this point, with large populations of veterans with PTSD, it has not yet been published in the scientific literature.
[Translation]
Senator Boisvenu: Dr. Weiss, I understand your answer very well. We know that treatments can have a short-term effect as well as a long-term effect.
Are the groups under study, those who received the medication, monitored over a long period of time after completing therapy, to see if these problems have returned? Once the treatment has ended, are these people allowed to return to their regular jobs? Is there any long-term follow-up?
[English]
Mr. Weiss: Thank you, senator, for that question. To date, the majority of the trials have been short term in nature and have looked at responses and improvements that occur during the treatment and for a relatively short period of time after the treatment. So there is no question that subsequent trials will also have to look at the long-term implications after the psychedelic-assisted psychotherapy is no longer administered to see whether or not it is maintained — if there is an improvement — for extended periods of time. Those studies have not yet been carried out, no.
The Chair: Thank you very much, Mr. Weiss. And I’m going to go to Ms. Priest, and see if she has anything to add to this conversation at the moment.
Ms. Priest: No, I don’t have anything to add but just to say that I’m very much enjoying listening and learning alongside of you. Most of our work is how to coordinate more effectively and share information about what’s working and that’s why I have really enjoyed listening to the discussion today with my colleagues. Thank you.
The Chair: Thank you. I have a quick question for any of the witnesses. I know it’s a slow process, but there are a lot of people suffering with PTSD and other implications of service. How long before the peer review is published? How long will it be before some kind of idea about the effectiveness of these drugs is finalized so people maybe can get the help they need if these drugs are actually beneficial?
Ms. Reynolds: You are talking about the trajectory of the research and the length of the research under way?
Mr. Weiss: Senator, I fully appreciate the fact that there are many veterans, as well as public safety personnel, front-line health care workers, refugees and immigrants and other Canadians who are suffering from PTSD. We work diligently every day to develop improved access to evidence-based treatments for all populations and, of course, in particular, our veterans.
I believe the mechanisms that are being undertaken to examine the effectiveness of psychedelic-assisted psychotherapy are done in a manner to ensure that the veterans get the best care and that we do no harm when new therapies are delivered. The time frames always seem achingly long, just like they do for new cancer treatments for people with terminal cancer and other chronic life-limiting illnesses.
I’m actually feeling that the world, including Canada, is collaborating very effectively on advancing as rapidly as possible psychedelic-assisted psychotherapy for those who need it, including veterans with PTSD. I am confident that the time frames are not being protracted for any reason, only to ensure that we protect those who protect us as well, such that when they are receiving treatments that are likely to benefit them and not harm them.
I imagine, when we look at the trials that are currently under way, that within the next two to three years, we should be much further ahead in our understanding of what works and what doesn’t work and who it works for. Again, that is taking into account that structured psychotherapy is already beneficial to many veterans who have PTSD. If we try to ensure that they have access to this psychotherapy and if it can be augmented with psychedelics, I would say within two to three years we’ll have a better idea how certain that evidence is and to what extent it can be made available to our veteran populations and others with PTSD.
But there is still a significant amount of work that needs to happen, not just in Canada but around the world. We have got our finger on the pulse, senator, and we’re not waiting. We’re advancing the science as rapidly as we can, and we are welcoming the input from colleagues around the world who are completing trials as we are completing trials. It is a global effort to try to advance this very promising avenue.
The Chair: Yes, sir. I am aware that the clinical studies are clinical studies and must be done with a great deal of caution. I’m a little worried as well about what happens after the clinical studies when these drugs become available on the street or within pharmaceutical avenues. I’m a little worried because, as Senator Boisvenu said previously, every individual is an individual, and there are negative effects of pharmaceuticals. I’m glad these clinical studies are proceeding with caution.
Senator Yussuff: Dr. Weiss, the State of Texas passed legislation last year that required a study on potential benefits of psychedelic treatment for veterans suffering from PTSD including, of course, clinical trials on the therapeutic effect of using psilocybin in treatment for those who are resistant to PTSD. To put it in context, the largest number of veterans in any one place in the United States is in the state of Texas, some 1.45 million, compared to Canada with about 600,000.
You have indicated that Veterans Affairs Canada has partnered with CIHR to do a study on the use of other therapies in regard to helping to treat veterans. If Veterans Affairs were to approach CIHR to do some similar study, like you have done around the use of cannabis, is that a possibility and, as such, would there be collaboration from CIHR and Veterans Affairs if they were to initiate such a proposal?
Mr. Weiss: Absolutely, we would welcome it, as we did when we collaborated on cannabis for chronic pain in veterans, which is a study currently under way, supported by funds from Veterans Affairs Canada. If Veterans Affairs Canada were to indicate to CIHR that it wished to sponsor additional trials, then we have the capacity to launch those funding opportunities and to make sure that the best researchers in the country would undertake that research in a manner that would yield important answers around effectiveness, side effects and the like.
Without going on too long about it, the short answer is yes; we’re always open to collaborate, and we do collaborate very effectively with Veterans Affairs Canada.
Senator Yussuff: Thank you very much, and let me say thanks for all the great work that CIHR is doing on so many fronts across the country. For us, in the context of this issue, I want to thank you and the other colleagues here today for your presentations.
Mr. Weiss: Thank you, senator.
The Chair: Before we go, I have a very quick question. If MDMA were to be approved in the United States, would it be fast-tracked here in Canada? Would that influence the Canadian government’s decision or Health Canada’s decision?
Ms. Reynolds: Thank you for the question. Our review would depend on the sponsor submitting a new drug submission to Canada. We are not influenced by the U.S. FDA decisions. We would need a sponsor with a new drug submission into Canada, and then we could review it. As I mentioned, we do have accelerated review pathways available to sponsors should they wish to apply for them, which would shorten our review times.
The Chair: Thank you very much, Dr. Weiss and witnesses and senators. This was an extremely productive meeting, and I now adjourn it.
(The committee adjourned.)